In early February 2020, Kirsten St. George and her team at New York state\u2019s public health lab received a test developed by the Centers for Disease Control and Prevention to diagnose people infected with the new, rapidly spreading coronavirus.<\/p>\n

But, like many labs around the country, it quickly found the test gave inaccurate results. So test samples had to be sent back to the CDC for processing, wasting time and leaving state officials \u201csort of blind to what the situation was with the disease,\u201d said St. George, chief of the laboratory of viral diseases at the Wadsworth Center, one of the nation\u2019s largest state public health labs.<\/p>\n

\u201cIt was extremely unfortunate that it happened at such a critical time, in the early days of this emerging pandemic,\u201d she said.<\/p>\n

An independent panel<\/a> of laboratory researchers, public health and policy experts, and doctors say the CDC\u2019s flawed diagnostic test was one of the \u201cmost consequential\u201d of the agency\u2019s pandemic missteps because it stymied national efforts to contain covid-19 as the disease spread.<\/p>\n

They blame the test\u2019s shortcomings on a series of problems rooted in how the CDC operated its laboratories: a lack of unified leadership for the labs developing the test; insufficient planning and quality control systems for producing tests for novel pathogens; and ineffective governance that sometimes placed clinical laboratory decisions in the hands of \u201cnon-laboratory experts\u201d without diagnostic testing expertise.<\/p>\n

The CDC says it\u2019s working to address its liabilities, using the findings of that advisory committee<\/a> as a guide. It\u2019s a big job \u2014 one further complicated by new leadership at the agency, constrained resources, and continued antagonism and threatened budget cuts from members of Congress.<\/p>\n

Failure to make sweeping changes could add to a growing lack of trust in the agency<\/a> post-pandemic and threaten the nation\u2019s preparedness for the next public health threat.<\/p>\n

\u201cIf the CDC can\u2019t change, their importance in health in the nation will decline,\u201d said Jill Taylor, a senior adviser for the Association of Public Health Laboratories. \u201cThe coordination of public health emergency responses in the nation will be worse off.\u201d<\/p>\n

The CDC\u2019s original covid test had two key problems, according to an internal analysis<\/a> in 2021 by a group of agency staff. A design flaw and contamination during production at the CDC led the tests to give false positive results.<\/p>\n

The work group that later performed an independent postmortem on the development of the test, using information provided by the CDC, came to the same conclusions.<\/p>\n

\u201cIt was all surprising to me,\u201d said Joshua Sharfstein, a vice dean at the Johns Hopkins Bloomberg School of Public Health, who co-chaired the panel.<\/p>\n

The panel concluded that these failures, fueled by problems within the agency, had human consequences.<\/p>\n

\u201cLacking awareness of how rapidly and widely the virus was spreading, public health agencies were slow to recommend behavior changes or implement protective measures,\u201d its February report said.<\/a><\/p>\n